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This is an open label phase II pilot study assessing the metabolomic and inflammatory effects of oral aspirin (ASA) in human subjects at risk for melanoma.
Primary Objectives
I. Open label trial in 60 patients to assess the capacity of either of one daily dose (81, 325 mg) of sub-chronic ASA administration to increase the plasma and nevus ASA metabolites such as: salicylate, salicylurate, gentisic acid, and salicyl acyl glucuronide.
II. Open label trial in 60 patients to assess the capacity of sub-chronic daily ASA (81, 325 mg) administration to reduce levels of prostaglandin E2 (PGE2) in plasma and nevi.
Secondary Objectives
I. Determine whether ASA increases AMP-activated protein kinase (AMPK) activation in nevi.
II. Determine whether ASA affects whole blood leukocytes or leukocyte subsets in plasma.
III. Determine whether ASA affects inflammatory cytokines in plasma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASA 81 mg daily | Experimental | Participants will be given ASA 81 mg orally once daily for a total of 7 days |
|
| ASA 325 mg daily | Experimental | Participants will be given ASA 325 mg orally once daily for a total of 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin 81 mg | Drug | ASA 81mg taken daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in concentration of ASA metabolites (salicylate and salicylurate) in plasma after ASA ingestion | Concentration (ng/mL) of pre-treatment ASA metabolites (salicylate and salicylurate) in plasma will be compared to the concentration of ASA metabolites at day 7 | Change from baseline to day 7 |
| Change in concentration of ASA metabolites in nevus tissue after ASA ingestion | Pre-treatment ASA metabolites in tissue will be compared to ASA metabolites at day 7 | Change from baseline to day 7 |
| Change in concentration of prostaglandin E2 (PGE2) in plasma after ASA ingestion | Baseline PGE2 levels in plasma specimens will be compared to PGE2 levels at day 7. | Change from baseline to day 7 |
| Change in concentration of prostaglandin E2 (PGE2) in nevus tissue after ASA ingestion | Baseline PGE2 levels in tissue specimens will be compared to PGE2 levels at day 7. | Change from baseline to day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in AMP-activated protein kinase (AMPK) activation in nevi after ASA ingestion | Quantitative densitometry analysis using Western blots will be performed on tissue collected at baseline and at day 7 to compare activation of AMP-activated protein kinase (AMPK). | Change from baseline to day 7 |
| Change in concentration of leukocytes in peripheral blood after ASA ingestion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas Grossman, MD | Huntsman Cancer Institute/ University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | 84112 | United States |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Aspirin 325mg | Drug | ASA 325mg taken daily |
|
|
Whole blood will be taken at baseline and at day 7 to compare concentration of leukocytes |
| Change from baseline to day 7 |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |